Director, Drug Safety Physician
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Job Description
Director Drug Safety Physician at Spyre Therapeutics leading safety reviews and compliance for antibody portfolio. Focused on pharmacovigilance and collaboration in clinical development.
Responsibilities:
- Perform triage and medical review of ICSRs (in or outside the global safety database), and oversight of cases/AOSE for expedited safety reporting
- Lead cross-functional medical review discussions pertaining to Individual Case Safety Report (ICSR) review.
- Participate in the preparation, writing, and/or review of aggregate safety review documents (DSUR) and safety sections of relevant clinical trial documents and regulatory filings.
- Participate in safety data review including safety surveillance activities and the evaluation & management of safety signals emerging from any data source.
- Participate and co-present cases at safety management team meetings and co-lead safety surveillance and signal management meetings.
- Participate in process improvement projects related to medical review and assessment, safety surveillance, and relevant aspects of PV compliance.
- Assist the DSPV department head in developing and maintaining state-of-the-art Pharmacovigilance (PV) processes and procedures including SOPs, WI, surveillance plans.
- Works closely and assists the Medical Review Lead on the ongoing review of cases and in developing a unified approach for medical review of ICSRs, safety presentations (relevant to medical review of ICSRs and/or safety surveillance aspects), and provides ongoing input on study protocols, periodic reports (DSUR), safety management plans etc.
- Participate in safety presentation development for independent Data Monitoring Committee (iDMC) meetings.
- Ensure that tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements.
- Provide medical safety strategy and execution of benefit-risk management strategies for assigned products.
- Provide safety input to clinical development plans, responses to HA or institutional review board/ ethics committee queries.
- Provide input into the development of safety risk language, risk management strategy, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review, and safety-focused publication development.
- Provide input to other safety activities as requested.
- Other duties as assigned.
Requirements:
- MD with 6+ years of related Clinical Development Drug Safety/Medical Review experience within the biotech/pharmaceutical industry
- Working experience / proficiency in Argus global safety database and medical review activities
- Knowledge of global pharmacovigilance regulations (EMA, FDA, etc.) relevant to the activities and responsibilities described above
- Excellent analytical and problem-solving skills, with the ability to interpret complex data and translate findings into actionable drug development strategies
- Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions.
Benefits:
- Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
- Unlimited PTO
- Two, one-week company-wide shutdowns each
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings to address complex problems and build relationships.
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